Clinical trials are key to determining the safety and efficacy of medicines. But to do so, trials must be robust and ethical—and their full results must be reported publicly. Unfortunately, many trials are not meeting this criteria. More and more are being off-shored to developing countries where they can be conducted more cheaply and with questionable ethical standards. Meanwhile, debate is growing around the use of early access schemes that allow for medicines to be put on the market based on smaller and shorter clinical trials. The European Medicines Agency (EMA) recently published a report on its ‘Adaptive Pathways’ pilot project, a new concept for medicine development and early access. In addition, discussions continue about the need to enhance clinical trial data transparency.
To discuss the globalisation and ethics of clinical trials, recent developments in clinical trial data transparency and evidence requirements for marketing authorisation, Health Action International and Public Eye (previously called the Berne Declaration) are holding a one-day public conference in Geneva, Switzerland, on Friday, 30 September. The day will wrap with discussion about the way forward for needs-driven biomedical research. The event is open to anyone interested in the topic. Keynote speakers and panelists include Hans-Georg Eichler (European Medicines Agency), Ghassan Karam (World Health Organization), Silvio Garattini (Mario Negri Institute for Pharmacological Research), Tom Jefferson (Centre for Evidence Based Medicine and Cochrane Acute Respiratory Infections Group X), Françoise Jaquet (Swissmedic), Jan Stadler (European Ombudsman), Teresa Alves (Prescrire), Beate Wieseler (IQWiG) and many others.
For more information, including the full list of speakers and the conference programme, visit the event webpage at www.haiweb.org/cdtconference. To register your attendance, email Patrick Durisch at firstname.lastname@example.org.